REGENXBIO Inc.
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Responsible for executing automation tasks related to design, implementation, and operational management of Process Control Systems and Building Automation Systems. Manage automation function, lead projects, provide technical support, develop SOPs, and perform system maintenance activities.
Contribute to the development, validation, and implementation of ligand-binding assays for quantifying biotherapeutic proteins, biomarkers, and assessing immunogenicity. Participate in project team activities, report and interpret bioanalytical results, and support drug discovery and development activities. Develop and validate PK/PD/immunogenicity assays. Write technical reports and present scientific findings at team meetings and external discussions.
Collaborate with a team to implement analytical methods and provide support for gene therapy products. Perform routine analysis using biophysical methods, qualify/validate assays, transfer analytical tech, maintain testing records, and troubleshoot method/instrument issues.
Seeking a qualified scientist with strong analytical skills to develop and optimize biophysical characterization methods for AAV-based gene therapy products. Responsible for analytical method development, qualification, validation, and tech transfer. Must have experience in analytical ultracentrifugation, particle size analysis, and thermodynamic analysis.
The Sr. Manager, Interactive Response Technologies (IRT) is responsible for managing and overseeing all Medical Organization IRT related systems and capabilities. This role involves establishing strong relationships with service providers, overseeing system planning and setup, managing integration with Clinical Operations and Clinical Supply systems, and ensuring compliance with regulatory requirements.
Lead Statistical Programming efforts for clinical trials at REGENXBIO, including developing and validating SAS programs, managing timelines, overseeing CROs, and mentoring junior programmers.